“It is not enough to do your best; you must know what to do, and then do your best.” - Edwards Deming

Product Development & Regulatory Roadmap

Product Development & Regulatory Roadmap

In order to bring a product to the market, pharma or biotech company will require a partner ready to provide you with a Product Development.
 
Clinmark Consulting Department supports clients on very early stage of product development by providing an optimal regulatory path and creating Product Development Plans that gives a practical knowledge, which trials should be performed for the specific product or Clinmark’s experts provide such expert advice in all areas of Product Development, starting from preclinical strategies, regulatory advice, study design and protocol preparation through other parts of a product development process.
The above-mentioned Plan includes the following products:

  • medicinal products,

  • veterinary medicinal products,

  • medical devices,

  • cosmetic products,

  • food supplements.

Preclinical Studies

Preclinical research aims to pre-assess the safety and efficacy of a potential drug before it is first used in humans. This is the initial phase of research on the drug, assessing its effect on cells (in vitro) and animal organisms (in vivo). Information from non-clinical studies is used in the planning of clinical trials involving humans. Clinmark provides full range of pre-clinical services covering pharmacological, toxicological and other tests depending on the type of product and the needs of our Client. Our company offers high quality services that are in compliance with applicable law, guidelines of the European Medicines Agency (EMA), ISO Standards, Good Laboratory Practice and Standard Operating Procedures (SOPs).

Study Results Description & Presentation

When the expected study data are collected, cleaned and the database is locked our scientific team is ready to analyze the data and process study results. The team consisted of biostatistician, study medical expert, and medical writer will develop the Clinical Study Report describing the process of protocol execution and the achieved results as well as the main results driven conclusions.

Due diligence

 Prior to business merges or acquisitions, we perform the assessment of a company to be acquired or merged. The appropriate, thorough evaluation and analysis of the company’s research pipeline, know-how and operational performance are part of the due diligence audit. People at Clinmark has competences to perform complex due diligence audits of biotech and pharmaceutical companies. In the due diligence process we assess the ongoing and planned research programs of the compounds in the pipeline, efficacy of operational processes, business threats, risks and limitations.

Expansion to new territories

In the world of globalization and increasing competition, a smooth and qualified conduct of clinical trial is becoming more and more challenging. One of the solutions to this challenge is venturing into new territories, in terms of projects execution, which are more attractive as for recruitment or cost-efficiency. However, the expansion to the unknown regions is connected with the increased risk of failure. Clinmark can help you make conscious decision about the expansion, plan and implement the expansion wisely and minimize the risk.

Dossier Preparation

Clinmark’s team has extensive expertise regarding Regulatory Affairs and is always ready to support Clients in all regulatory aspects. Our Experts assist in dossier preparation and submission process of the following products:  

  • medicinal products - Common Technical Document (CTD, eCTD)

  • veterinary medicinal products - Common Technical Document (CTD, eCTD)

  • medical devices - Technical Documentation (TD)

  • cosmetic products - Product Information File (PIF)

  • food supplements - Food Supplement Documentation

Product Registration

Clinmark’s team evaluates existing documentation in order to manage marketing authorisation process through one of these procedures available in the EU.

Clinmark can provide advice from dossier preparation and submission through marketing authorization support (also for companies from non-EU countries). Clinmark’s consultants can guide the Clients through the whole regulatory process and provide one with full-service solutions at any stage of product development.

CE Mark

In order to commercialize medical devices in the European Union, a CE Mark certificate is needed. This certification verifies that a device meets all regulatory requirements for medical devices under the new Medical Devices Regulation (MDR 2017/745). Clinmark’s team has wide experience in the preparation and planning of every stage of CE Marking Regulatory Process. Our experts assist the Customers in the conformity assessment of a medical device in cooperation with a notified body.